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Clinical Trial Details

Trial ID: L2258
Source ID: NCT04027530
Associated Drug: Ertugliflozin 15 Mg
Title: Renal Oxygenation, Oxygen Consumption and Hemodynamic Kinetics in Type 2 DIabetes: an Ertugliflozin Study.
Acronym: ROCKIES
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus|Diabetic Kidney Disease|Diabetic Nephropathy|Renal Hypoxia|Renoprotection|SGLT2 Inhibitor|Ertugliflozin
Interventions: DRUG: Ertugliflozin 15 mg
Outcome Measures: Primary: Renal oxygenation measured by BOLD-MRI (R2*), Renal (separated as cortical and medullar) oxygenation measured by BOLD-MRI (R2\*), After 4 week treatment with ertugliflozin 15mg QD versus placebo | Secondary: Renal oxygen consumption by PET/CT-scan using 11C-Acetate, Renal oxygen consumption will be measured by PET/CT-scan using 11C-Acetate and compartment model parameter k2, After 4 week treatment with active drug intervention versus placebo|Renal hemodynamics, GFR and ERPF, After 4 week treatment with active drug intervention versus placebo|Renal efficiency, Measured as sodium reabsorption divided by oxygen consumption, After 4 week treatment with active drug intervention versus placebo|Cortical blood flow, measured by contrast-enhanced ultrasound, After 4 week treatment with active drug intervention versus placebo|Renal arterial blood flow, measured by arterial spin labelling, After 4 week treatment with active drug intervention versus placebo|Acute 24-hour sodium and glucose excretion, 24-hour sodium and glucose excretion after 2 days * Urine osmolality * Urinary pH, After 2 days of treatment with active drug intervention versus placebo|Chronic 24-hour sodium and glucose excretion, 24-hour sodium and glucose excretion after 4 weeks, After 4 week treatment with active drug intervention versus placebo|Renal tubular function: Urinary pH, Urinary pH, After 4 week treatment with active drug intervention versus placebo|Renal tubular function: Urine Osmolality, Urine osmolality, After 4 week treatment with active drug intervention versus placebo|Renal tubular function: sodium transport, Iohexol corrected sodium excretion, After 4 week treatment with active drug intervention versus placebo|Renal damage markers, Renal damage markers will include: urinary albumin excretion in 24-hour urine samples and other markers depending on relevant (emerging) metabolic and humoral biomarkers of renal damage, conditional to available budget., After 4 week treatment with active drug intervention versus placebo|Changes in plasma energy substrate: glucose, Changes in plasma energy substrate: glucose, After 4 week treatment with active drug intervention versus placebo|Changes in plasma energy substrate: free fatty acids, Changes in plasma energy substrate: free fatty acids, After 4 week treatment with active drug intervention versus placebo|Changes in plasma energy substrate: ketone bodies, Changes in plasma energy substrate: ketone bodies, After 4 week treatment with active drug intervention versus placebo|Changes in plasma energy substrate:triglycerides, Changes in plasma energy substrate:triglycerides, After 4 week treatment with active drug intervention versus placebo|Energy expenditure, By resting energy expenditure, After 4 week treatment with active drug intervention versus placebo|Changes in erythropoietin (EPO) levels, Changes in erythropoietin (EPO) levels, After 4 week treatment with active drug intervention versus placebo|Insulin sensitivity, OGIS and Matsuda Index during an oral glucose tolerance test (OGTT), After 4 week treatment with active drug intervention versus placebo|Beta-cell function, Beta-cell function will be derived from HOMA-B modelling during an oral glucose tolerance test (OGTT)., After 4 week treatment with active drug intervention versus placebo|Peripheral insulin extraction, Arterial-venous difference before and following an OGTT, After 4 week treatment with active drug intervention versus placebo|Total insulin extraction, Arterial-venous difference before and following an OGTT, After 4 week treatment with active drug intervention versus placebo
Sponsor/Collaborators: Sponsor: Amsterdam UMC, location VUmc
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2020-12-10
Completion Date: 2023-01-09
Results First Posted:
Last Update Posted: 2023-05-01
Locations: VU University Medical Center, Amsterdam, 1081 HV, Netherlands
URL: https://clinicaltrials.gov/show/NCT04027530